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1.
J Strength Cond Res ; 34(4): 1184-1187, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-30418328

RESUMEN

McKay, BD, Miramonti, AA, Gillen, ZM, Leutzinger, TJ, Mendez, AI, Jenkins, NDM, and Cramer, JT. Normative reference values for high school-aged American football players: Proagility drill and 40-yard dash split times. J Strength Cond Res 34(4): 1184-1187, 2020-The purpose of this short report was to provide test- and position-specific normative reference values for the 10- and 20-yd split times (10YD and 20YD) during the 40-yd dash (40YD) as well as 10-yd split times during the proagility drill (PA) based on a large, nationally representative sample of high school-aged American football players in their freshman, sophomore, and junior classes. Cross-sectional performance data were obtained from 12 different high school American football recruiting combines between March 7, 2015, and January 9, 2016, across the United States. The sample included (n = 7,478) high school-aged American football athletes in their freshman (n = 1,185), sophomore (n = 2,514), and junior (n = 3,779) classes. Each player self-classified their American football positions as defensive back, defensive end, defensive linemen, linebacker, offensive linemen (OL), quarterback (QB), running back, tight end, or wide receiver. The results of the freshman, sophomore, and junior class were aggregated to generate test- and position-specific normative values. Mean differences were found among classes for all positions and all measurements (p ≤ 0.05) except for OL and QB PA split time (p > 0.05). Greater percent differences for all 3 variables were observed between freshman and sophomore years than between sophomore and junior years. These normative reference values will be useful for athletes, parents, coaches, and high school strength and conditioning professionals to set realistic goals for young American football athletes.


Asunto(s)
Rendimiento Atlético/fisiología , Fútbol Americano/fisiología , Carrera/fisiología , Adolescente , Atletas , Pesos y Medidas Corporales , Estudios Transversales , Humanos , Masculino , Valores de Referencia , Estados Unidos
2.
J Strength Cond Res ; 34(10): 2849-2856, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-29489728

RESUMEN

McKay, BD, Miramonti, AA, Gillen, ZM, Leutzinger, TJ, Mendez, AI, Jenkins, NDM, and Cramer, JT. Normative reference values for high school-aged American football players. J Strength Cond Res 34(10): 2849-2856, 2020-The purpose of the present report was to provide test- and position-specific normative reference values for combine test results based on a large, nationally representative sample of high school-aged American football players in their freshman, sophomore, and junior classes. Cross-sectional anthropometric and performance data were obtained from 12 different high school American football recruiting combines between March 7, 2015, and January 9, 2016, across the United States. Subjects included a sample (n = 7,478) of high school-aged American football athletes in their junior (n = 3,779), sophomore (n = 2,514), and freshman (n = 1,185) classes. The database included combine date, school state, position, class, height, body mass (BM), 40-yard dash, pro-agility, 3-cone, vertical jump, broad jump, and power push-up. Each player self-classified their American football positions as defensive back, defensive end, defensive linemen, linebacker, offensive linemen, quarterback, running back, tight end (TE), or wide receiver. Test- and position-specific normative values were generated by aggregating data from freshman, sophomore, and junior classes. Mean differences were found among classes for all positions and all measurements (p ≤ 0.05), except for TE BM (p > 0.05). Greater differences for all variables were observed from freshman to sophomore classes than from sophomore to junior classes. These normative reference values may provide realistic comparisons and evaluations in performance for young American football players, parents, and coaches with collegiate football aspirations. High school strength and conditioning professionals should use these norms to set attainable goals and reward accomplishments for young football players.


Asunto(s)
Atletas , Rendimiento Atlético/fisiología , Rendimiento Atlético/normas , Fútbol Americano/fisiología , Fútbol Americano/normas , Adolescente , Adulto , Antropometría , Estatura , Índice de Masa Corporal , Estudios Transversales , Prueba de Esfuerzo , Humanos , Masculino , Valores de Referencia , Carrera/fisiología , Carrera/normas , Estados Unidos , Universidades
3.
J Strength Cond Res ; 32(5): 1288-1296, 2018 May.
Artículo en Inglés | MEDLINE | ID: mdl-29389695

RESUMEN

Leutzinger, TJ, Gillen, ZM, Miramonti, AM, McKay, BD, Mendez, AI, and Cramer, JT. Anthropometric and athletic performance combine test results among positions within grade levels of high school-aged American football players. J Strength Cond Res 32(5): 1288-1296, 2018-The purpose of this study was to investigate differences among player positions at 3 grade levels in elite, collegiate-prospective American football players. Participants' data (n = 7,160) were analyzed for this study (mean height [Ht] ± SD = 178 ± 7 cm, mass [Bm] = 86 ± 19 kg). Data were obtained from 12 different high school American football recruiting combines hosted by Zybek Sports (Boulder, Colorado). Eight 2-way (9 × 3) mixed factorial analysis of variances {position (defensive back [DB], defensive end, defensive lineman, linebacker, offensive lineman [OL], quarterback, running back, tight end, and wide receiver [WR]) × grade (freshmen, sophomores, and juniors)} were used to test for differences among the mean test scores for each combine measure (Ht, Bm, 40-yard [40 yd] dash, proagility [PA] drill, L-cone [LC] drill, vertical jump [VJ], and broad jump [BJ]). There were position-related differences (p ≤ 0.05) for Ht, 40 yd dash, and BJ, within each grade level and for Bm, PA, LC, and VJ independent of grade level. Generally, the results showed that OL were the tallest, weighed the most, and exhibited the lowest performance scores among positions. Running backs were the shortest, whereas DBs and WRs weighed the least and exhibited the highest performance scores among positions. These results demonstrate the value of classifying high school-aged American football players according to their specific position rather than categorical groupings such as "line" vs. "skill" vs. "big skill" when evaluating anthropometric and athletic performance combine test results.


Asunto(s)
Rendimiento Atlético/fisiología , Fútbol Americano/fisiología , Adolescente , Factores de Edad , Antropometría , Pesos y Medidas Corporales , Estudios Transversales , Humanos , Masculino , Estudios Prospectivos , Carrera , Estados Unidos
4.
J Strength Cond Res ; 32(1): 83-96, 2018 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-29084096

RESUMEN

Gillen, ZM, Miramonti, AA, McKay, BD, Jenkins, NDM, Leutzinger, TJ, and Cramer, JT. Reliability and sensitivity of the power push-up test for upper-body strength and power in 6-15-year-old male athletes. J Strength Cond Res 32(1): 83-96, 2018-The power push-up (PPU) test is an explosive upper-body test performed on a force plate and is currently being used in high school football combines throughout the United States. The purpose of this study was to quantify the reliability of the PPU test based on age and starting position (knees vs. toes) in young athletes. Sixty-eight boys (mean ± SD; age = 10.8 ± 2.0 years) were tested twice over 5 days. Boys were separated by age as 6-9 years (n = 16), 10-11 years (n = 26), and 12-15 years (n = 26). The PPU test was performed on a force plate while rotating from the knees vs. the toes. Measurements were peak force (PF, N), peak rate of force development (pRFD, N·s), average power (AP, W), and peak power (PP, W). Intraclass correlation coefficients (ICC2,1), SEMs, coefficients of variation (CVs), and minimum detectable changes (MDCs) were calculated to quantify reliability and sensitivity. Peak force from the knees in 10-15-year-olds, PF from the toes in 12-15-year-olds, and pRFD from the knees and toes in 12-15-year-olds were comparably reliable (ICC ≥ 0.84). Neither power measurements (AP or PP) for any age group, nor any measurements (PF, pRFD, AP, or PP) for the 6-9-year-olds were comparably reliable (ICC ≤ 0.74). When considering the reliable variables, PF was greater in the 12-15-year-olds than in 10-11-year-olds (p ≤ 0.05). In addition, in 12-15-year-olds, PF and pRFD were greater from the knees than from the toes (p ≤ 0.05). For reasons largely attributable to growth and development, the PPU test may be a reliable (ICC ≥ 0.80) and sensitive (CV ≤ 19%) measure of upper-body strength (PF), whereas pRFD was also reliable (ICC ≥ 0.80), but less sensitive (CV = 30-38%) in 10-15-year-old male athletes.


Asunto(s)
Atletas , Prueba de Esfuerzo/métodos , Fuerza Muscular/fisiología , Músculo Esquelético/fisiología , Adolescente , Niño , Prueba de Esfuerzo/normas , Humanos , Masculino , Reproducibilidad de los Resultados
5.
J Strength Cond Res ; 32(10): 2783-2794, 2018 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-29465606

RESUMEN

Gillen, ZM, Miramonti, AA, McKay, BD, Leutzinger, TJ, and Cramer, JT. Test-retest reliability and concurrent validity of athletic performance combine tests in 6-15-year-old male athletes. J Strength Cond Res 32(10): 2783-2794, 2018-Athletic performance combine tests are used by high school, collegiate, and professional American football programs to evaluate performance; however, limited evidence is available on performance combine test results in youth athletes. The purposes of this study were to report test-retest reliability statistics and evaluate concurrent validity among combine performance tests in 6-15-year-old male athletes. Sixty-nine young male athletes (mean ± SD; age = 10.9 ± 2.1 years, height = 154.4 ± 13.6 cm, body mass = 46.8 ± 16.0 kg) were divided into 3 age groups: 6-9 years (n = 16), 10-11 years (n = 26), and 12-15 years (n = 27). Participants completed 2 attempts of the vertical jump (VJ), broad jump (BJ), pro-agility (PA), L-cone (LC) drill, and 10-, 20-, 40-yd dashes. The results indicated that the older age groups performed better on most performance assessments compared with the 6-9-year group (p ≤ 0.05). The combine tests demonstrated consistently adequate reliability for all age groups, except for the 10-yd dash, which was deemed unreliable. Evidence of concurrent validity, and possible measurement redundancy were observed in the VJ vs. BJ, PA vs. LC, and 20 vs. 40 yd, but zero- and first-order partial correlations suggested that only the PA and LC were redundant, and the PA may be superior for this age group over the LC. Although the VJ and BJ provide independent performance information regarding lower-body power, questions regarding the redundancy of the 20 vs. 40 yd remain unanswered from a measurement perspective.


Asunto(s)
Rendimiento Atlético/fisiología , Prueba de Esfuerzo/normas , Reproducibilidad de los Resultados , Adolescente , Atletas , Niño , Estudios Transversales , Humanos , Masculino
6.
J Strength Cond Res ; 32(11): 3119-3126, 2018 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-30540280

RESUMEN

Mendez, AI, Miramonti, AA, Gillen, ZM, McKay, BD, Leutzinger, TJ, and Cramer, JT. Stature, body mass, and BMI in high school american football players: Appropriate determinants of obesity prevalence? J Strength Cond Res 32(11): 3119-3126, 2018-The purpose of this study was to evaluate stature (HT), mass (BM), body mass index (BMI), and obesity prevalence based on BMI categories in a large sample (n = 7,175) of high school American football players enrolled as freshmen, sophomores, or juniors. Players were categorized by their positions: offensive linemen (OLs), defensive linemen (DLs), tight end, defensive end, linebacker, running back, quarterback, defensive back, and wide receiver. The HT, BM, and BMI increased as grade increased among all positions. Offensive lineman and DL had the greatest HT, BM, and BMI (p ≤ 0.05). Obesity prevalence was greatest in OL and DL. When accounting for age-related increases in BMI, BM increased to a greater degree than HT. If HT is an indirect indicator of skeletal size, although BM is more influenced by soft tissue, then the age-related BMI increases in this study may be largely accounted for by soft-tissue changes rather than skeletal growth. Although obesity prevalence in OL (94.5%) and DL (78.4%) positions was greater than all other positions as determined from BMI, it is impossible to know the allocations of fat-free and fat mass-particularly in American football athletes. If obesity continues to be defined as an unhealthy accumulation of fat, then athletes who may have a greater relative proportion of lean soft tissue should not be classified as obese using BMI (BM ÷ HT). More sophisticated, reliable, and sensitive measure of body composition, such as skinfolds, may be more appropriate field measurements.


Asunto(s)
Estatura , Índice de Masa Corporal , Fútbol Americano , Obesidad/epidemiología , Adolescente , Atletas , Composición Corporal , Humanos , Masculino , Prevalencia , Instituciones Académicas , Estados Unidos
7.
Ann Phys Rehabil Med ; 67(3): 101793, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38118246

RESUMEN

BACKGROUND: The most common symptom of peripheral artery disease (PAD) is intermittent claudication that involves the calf, thigh, and/or buttock muscles. How the specific location of this leg pain is related to altered gait, however, is unknown. OBJECTIVES: We hypothesized that because the location of claudication symptoms uniquely affects different leg muscle groups in people with PAD, this would produce distinctive walking patterns. METHODS: A total of 105 participants with PAD and 35 age-matched older volunteers without PAD (CTRL) were recruited. Participants completed walking impairment questionnaires (WIQ), Gardner-Skinner progressive treadmill tests, the six-minute walk test, and we performed an advanced evaluation of the biomechanics of their overground walking. Participants with PAD were categorized into 4 groups according to their stated pain location(s): calf only (C, n = 43); thigh and calf (TC, n = 18); buttock and calf (BC, n = 15); or buttock, thigh, and calf (BTC, n = 29). Outcomes were compared between CTRL, C, TC, BC and BTC groups using a one-way ANOVA with post-hoc comparisons to identify and assess statistically significant differences. RESULTS: There were no significant differences between CTRL, C, TC, BC and BTC groups in distances walked or walking speed when either pain-free or experiencing claudication pain. Each participant with PAD had significantly dysfunctional biomechanical gait parameters, even when pain-free, when compared to CTRL (pain-free) walking data. During pain-free walking, out of the 18 gait parameters evaluated, we only identified significant differences in hip power generation during push-off (in C and TC groups) and in knee power absorption during weight acceptance (in TC and BC groups). There were no between-group differences in gait parameters while people with PAD were walking with claudication pain. CONCLUSIONS: Our data demonstrate that PAD affects the ischemic lower extremities in a diffuse manner irrespective of the location of claudication symptoms. DATABASE REGISTRATION: ClinicalTrials.gov NCT01970332.


Asunto(s)
Claudicación Intermitente , Enfermedad Arterial Periférica , Humanos , Marcha/fisiología , Claudicación Intermitente/etiología , Pierna , Dolor/etiología , Enfermedad Arterial Periférica/complicaciones , Caminata/fisiología
8.
PLoS One ; 17(7): e0264598, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35830421

RESUMEN

Different levels of arterial occlusive disease (aortoiliac, femoropopliteal, multi-level disease) can produce claudication symptoms in different leg muscle groups (buttocks, thighs, calves) in patients with peripheral artery disease (PAD). We tested the hypothesis that different locations of occlusive disease uniquely affect the muscles of PAD legs and produce distinctive patterns in the way claudicating patients walk. Ninety-seven PAD patients and 35 healthy controls were recruited. PAD patients were categorized to aortoiliac, femoropopliteal and multi-level disease groups using computerized tomographic angiography. Subjects performed walking trials both pain-free and during claudication pain and joint kinematics, kinetics, and spatiotemporal parameters were calculated to evaluate the net contribution of the calf, thigh and buttock muscles. PAD patients with occlusive disease affecting different segments of the arterial tree (aortoiliac, femoropopliteal, multi-level disease) presented with symptoms affecting different muscle groups of the lower extremity (calves, thighs and buttocks alone or in combination). However, no significant biomechanical differences were found between PAD groups during the pain-free conditions with minimal differences between PAD groups in the claudicating state. All statistical differences in the pain-free condition occurred between healthy controls and one or more PAD groups. A discriminant analysis function was able to adequately predict if a subject was a control with over 70% accuracy, but the function was unable to differentiate between PAD groups. In-depth gait analyses of claudicating PAD patients indicate that different locations of arterial disease produce claudication symptoms that affect different muscle groups across the lower extremity but impact the function of the leg muscles in a diffuse manner generating similar walking impairments.


Asunto(s)
Pierna , Enfermedad Arterial Periférica , Marcha/fisiología , Humanos , Claudicación Intermitente/diagnóstico , Enfermedad Arterial Periférica/diagnóstico por imagen , Caminata/fisiología
9.
Neurorehabil Neural Repair ; 35(7): 563-575, 2021 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-33978525

RESUMEN

BACKGROUND: Individuals poststroke experience gait asymmetries that result in decreased community ambulation and a lower quality of life. A variety of studies have utilized split-belt treadmill training to investigate its effect on gait asymmetry, but many employ various methodologies that report differing results. OBJECTIVE: The purpose of this meta-analysis was to determine the effects of split-belt treadmill walking on step length symmetry in individuals poststroke both during and following training. METHODS: A comprehensive search of PubMed/MEDLINE, CINAHL, Web of Science, and Scopus was conducted to find peer-reviewed journal articles that included individuals poststroke that participated in a split-belt treadmill walking intervention. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) was used to assess risk of bias. Pooled Hedge's g with random effects models were used to estimate the effect of split-belt training on step length symmetry. RESULTS: Twenty-one studies were assessed and included in the systematic review with 11 of them included in the meta-analysis. Included studies had an average STROBE score of 16.2 ± 2.5. The pooled effects for step length asymmetry from baseline to late adaptation were not significant (g = 0.060, P = .701). Large, significant effects were found at posttraining after a single session (g = 1.04, P < .01), posttraining after multiple sessions (g = -0.70, P = .01), and follow-up (g = -0.718, P = .023). CONCLUSION: Results indicate split-belt treadmill training with the shorter step length on the fast belt has the potential to improve step length symmetry in individuals poststroke when long-term training is implemented, but randomized controlled trials are needed to confirm the efficacy of split-belt treadmill training.


Asunto(s)
Terapia por Ejercicio , Trastornos Neurológicos de la Marcha/rehabilitación , Rehabilitación de Accidente Cerebrovascular , Accidente Cerebrovascular/terapia , Caminata , Trastornos Neurológicos de la Marcha/etiología , Humanos , Evaluación de Resultado en la Atención de Salud , Accidente Cerebrovascular/complicaciones
10.
Clin Nutr ; 40(6): 3718-3728, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-34130017

RESUMEN

BACKGROUND & AIMS: Consumption of rapid digesting sugars by children are under increased scrutiny because of their contribution to unhealthy weight gain. Previous studies in adults and children have suggested that altering the blend of carbohydrates (CHOs) consumed may cause shifts in substrate utilization. The purpose of this study was to examine the effects of consuming a slow digesting carbohydrate (SDC) and rapid digesting carbohydrate (RDC) on CHO and fat oxidation, glucose, and insulin responses at rest, during exercise, and post-exercise rest in pre-pubescent children. METHODS: A randomized, double-blind, crossover design was used. Nineteen pre-pubescent children (n = 10 boys, n = 9 girls, mean ± standard error, age = 9.84 ± 0.37-yrs) participated. Visits to the laboratory began with a 30-min measurement of resting metabolism followed by consumption of either an RDC or SDC drink. Postprandial resting metabolism was recorded for 60-min, immediately followed by 60-min of submaximal cycling exercise while metabolism was recorded, which was immediately followed by another 60-min recording of post-exercise metabolism. Total CHO and fat oxidation, endogenous and exogenous CHO oxidation, blood glucose, and insulin were assessed. RESULTS: Total CHO oxidation rate (g∙min-1) was greater after the RDC drink at 60 min (p = 0.032). Endogenous CHO oxidation rate (g∙min-1) was greater after the SDC drink at 15 min (p ≤ 0.010). Cumulative endogenous CHO oxidation (g) was greater after the SDC drink at 45 min (p = 0.009). Endogenous CHO oxidation accounted for a greater proportion of substrate oxidation after the first 60-min rest period (p = 0.028), while exogenous CHO oxidation accounted for a greater proportion of substrate oxidation for the RDC at all time points (p ≤ 0.019). CONCLUSIONS: The present study provides novel data suggesting that an SDC promotes greater endogenous substrate utilization in pre-pubertal children, which may have beneficial health impacts on energy intake and carbohydrate regulation/metabolism during growth and development. CLINICAL TRIALS REGISTRY NUMBER: NCT03185884, clinicaltrials.gov.


Asunto(s)
Metabolismo de los Hidratos de Carbono , Carbohidratos de la Dieta/metabolismo , Metabolismo Energético , Oxidación-Reducción , Glucemia/metabolismo , Niño , Estudios Cruzados , Grasas de la Dieta/metabolismo , Método Doble Ciego , Ejercicio Físico , Femenino , Humanos , Insulina/metabolismo , Masculino , Consumo de Oxígeno , Periodo Posprandial
11.
Front Sports Act Living ; 2: 569932, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33345128

RESUMEN

Total knee arthroplasty is a common surgical treatment to improve ambulatory function for individuals with end-stage osteoarthritis of the knee. Functional and self-reported measures are widely used to assess functional ability and impairment before and after total knee arthroplasty. However, clinical assessments have limitations and often provide subjective and limited information. Seamless gait characteristic monitoring in the real-world condition is a viable alternative to address these limitations, but the effectiveness of using wearable sensors for knee treatment is unclear. The purpose of this study was to determine if inertial gait variables from wearable sensors effectively estimate the questionnaire, performance (6-min walk test, timed up and go, and 30-s chair stand test), and isometric measure outcomes in individuals after unilateral total knee arthroplasty. Eighteen subjects at least 6 months post-surgery participated in the experiment. In one session, three tasks, including self-reported surveys, functional testing, and isometric tests were conducted. In another session, the participants' gait patterns were measured during a 1-min walking test at their self-selected gait speed with two accelerometers worn above the lateral malleoli. Session order was inconsistent between subjects. Significant inertial gait variables were selected using stepwise regressions, and the contributions of different categories of inertial gait variables were examined using hierarchical regressions. Our results indicate inertial gait variables were significantly correlated with performance test and questionnaire outcomes but did not correlate well with isometric strength measures. The findings demonstrate that wearable sensor-based gait analysis may be able to help predict clinical measures in individuals after unilateral knee treatment.

12.
Metabol Open ; 7: 100041, 2020 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-32812942

RESUMEN

PURPOSE: The purposes of the present study were to (a) examine resting metabolism, substrate utilization, and endogenous versus exogenous carbohydrate (CHO) oxidation before and after 30-g rapidly-digesting carbohydrate (RDC) ingestion using indirect calorimetry and breath test analysis of stable isotope concentrations in pre-pubescent children and (b) report the 13C abundances in foods consumed for three days prior. METHODS: Nineteen children (n = 10 boys, n = 9 girls) at Tanner stage I or II participated (mean age ± 95% CI = 9.84 ± 0.77 y) in this study. Food was administered to the children for three days preceding their scheduled breath tests. Breath tests and indirect calorimetry were performed after an 8-h fast before and 60 min following consumption of a 30-g simple RDC drink consisting of maltodextrin and sucrose. Open circuit spirometry and indirect calorimetry monitored resting metabolism and CHO oxidation. Separate breath samples were taken every 15 min. Samples of all foods and breath samples were analyzed for 13C and 12C abundances with a stable-isotope mass spectrometer. RESULTS: 13C in expired breath samples were -23.81 ± 1.64‰ at baseline and increased every 15 min after consumption of the CHO drink (p < 0.001-0.009). Cumulative total, endogenous, and exogenous CHO utilization increased during the post-prandial period (p < 0.001). Endogenous CHO oxidation was consistently greater than exogenous CHO oxidation (p < 0.001-0.002).Blood glucose was elevated from baseline at 30- and 60-min post-prandial (p < 0.001). Insulin did not change over time (p = 0.184). CONCLUSIONS: The foods provided during the 3-day controlled diet effectively minimized 13C variation prior to metabolic testing. The 13C abundances of foods reported herein should serve as practical recommendations to reduce 13C intake before breath tests. While endogenous CHO oxidation remained greater in proportion to exogenous CHO oxidation, these findings suggest that even a relatively small amount of RDC can increase exogenous CHO oxidation and blood glucose in normal-weight children. To further examine shifts in endogenous versus exogenous CHO utilization, we recommend that future studies take steps to minimize 13C variation before breath tests and examine changes in substrate metabolism at rest and during exercise in normal weight and overweight pre-pubescent children. CLINICAL TRIAL REGISTRATION NUMBER: NCT03185884.

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